Events

Vital Signs A GE Healthcare Company 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Vital Signs Devices, a GE Healthcare Company 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    59047
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-2848-2011
  • 사례 시작날짜
    2011-04-29
  • 사례 출판 날짜
    2011-07-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-08-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100921
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Anesthesia Breathing Circuit - Product Code BYD
  • 원인
    The hygroscopic condenser humidifier (hch) device may have an occlusion that can prevent proper flow of the medical gases or oxygen, possibly resulting in insufficient oxygen delivered to the patient.
  • 조치
    An "Urgent Medical Device Correction" letter with the return confirmation form was sent to affected customers. Phone calls were also placed to customers. Consignees were informed of the affected device, issue, and actions to take. Customers were instructed to isolate all affected product, arrange return by contacting Customer Service at 1-800-932-0760, and return only unused product. Customers were asked to complete the attached confirmation form and fax back as per the instructions. For questions, contact your local Vital Signs Account Manager or call Customer service at 1-800-932-0760.

Device

Vital Signs A GE Healthcare Company
  • 모델명 / 제조번호(시리얼번호)
    Medical Device Listing number D110120.  5020AEHM 11087A  11098B 5701 5301C  5344E  5348V  5353K  5366T 5701E 5346Z 5702 5301D A0F52014 11091A  11098B A4112X14 11070A A415112A 11098B A41X2X24 11092A A4612X2C 11077A  11081B  11095B  11098A A4F12014 11075A  11084B  11090B  11091A  11094A  11101B  11091A  11101A A4F52X10 11075B  11077B  11082A  11090A A4F52X14 11074B A4U12214 11080B  11092A  11097A  11098A  11101A A4U52X1X 11083A  11087A  11090A A5152914 11077B  11080A A52X2314 11081A  11091A  11096B A5632X15 11070A  11095A A565192X 11094A  11095A  11095B  11096A  11097A A5U32020 11070A  11070B  11074B  11077B  11081A  11081B  11083A  11087A  11087B  11090A  11092A  11094B  11097A  11098A  11101A  11102A  11102B A5U32414 11077B  11080A  11082A  11082B  11090A  11094A  11094B  11097A  11097B  11098A A5U32X14 11076B  11083B  11084A A5U32X24 11070A  11077A  11080A  11083B  11087B  11098B  11101A  11102B A5U5201XX1 11076B  11083A  11088A  11090A  11101A A5W32014 11077A  11090B A5Z51914 11069B  11070A  11084A  11097B A8T52914 11082B A8U52015 11069A  11075A  11075B  11083B  11091A  11101B A8U5211X 11094A A8U52X14 11075A  11077A  11083A  11090B A8W52914 11069A  11083A  11088A  11094A A9U5211X 11080A  11090B  11094A AD132X14 11073A  11074A  11075A  11088A  11095B  11096B AD152914 11074B AD632X11 11070A  11073A  11074A  11081A  11083A ADA52014 11076A ADG5291X 11101B ADU12914 11074A  11074B  11075A  11087A  11090B  11094B  11098B  11101A  11101B ADU52914 11073A  11074A  11075A  11077A ADW32014 11073A  11083A  11087A  11094A  11098A  11098B  11101A AFN52024 11074A  11083B  11084A  11091B  11096A  11098B AFN5291C 11069B  11070B  11083A  11090A  11098A AFN52X1X 11070B  11088A AFR5191X 11069B AFR58014 11069B  11076A  11098B  11101A  11101B AFR5XX20 11073B  11101A AGN1QX1C 11070A  11070B  AGN5241C 11071A  11073A  11074B  11091A  11091B  11094A AIN52014 11070A  11074A  11075A  11076A  11082B  11083B  11087A  11087B  11090A  11095B  11101A AXXXX111 11075A  11098A AXXXXX83 11095B AXXXXX89 11095B B1154X14 11076A  11095A B1353X2X 11095A B1514X11 11073A  11098B B1534X15 11074B  11077B  11090A  11096A B1734X1Z 11069A  11091A B8734X24 11070A  11074A  11088A B9154X14 11073B  11098B G64X0XAX 11076B  11098A GABCXXXX 11087B  11088B  11094A  11096A GAK1OXXX 11076A  11076B  11083B  11084A  11084B  11087A  11087B  11088A  11095A  11095B  11096B  11097A GCEXXXXA 11082B  11087B  11097A  11098A GCRCKXXX 11070A  11091A GE9C0XAX 11083B  11101B GF1XXXAX 11070A  11084A  11088A  11088A  11101B GF7FOXGX 11069B  11083A  11083B GFJCXXXX 11084A  11102A GGYF0XAX 11080A  11098B GHAFXXXX 11080B  11082B  11087A  11088B  11094A  11094B  11094B  11095B  11098B GHBXXXXA 11070A  11070B  11075A  11087B  11091A  11095A GKXFXXAX 11073B  11080A  11094B GMAXXXJX 11094A  11098A  11098B GT1XXXJX 11070A GWKXXXGX 11074A  11083A  11090A  11098B GXXXXX67 11069B  11070A  11081A  11081B  11084B  11084B GXXXXX97 11073A  11101A GXXXXXX3 11087A  11094B
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution including the United States.
  • 제품 설명
    Vital Signs- A GE Healthcare Company - Hygroscopic Condenser Humidifier (HCH)/Anesthesia Breathing Circuit; GE Medical Systems SCS 283 rue de la Miniere 78530 BUC, France p +33.1.30.70.40.40; Vital Signs Colorado Inc 11039 E. Lansing Circle Englewood, CO 80112 P +1.973.956.5300. || The intended use of the device is to provide proper flow of the medical gases or oxygen to patients under anesthesia or ventilation.
  • Manufacturer
    Vital Signs Devices, a GE Healthcare Company

Manufacturer

Vital Signs Devices, a GE Healthcare Company
  • 제조사 주소
    Vital Signs Devices, a GE Healthcare Company, 20 Campus Rd, Totowa NJ 07512-1210
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA